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Welcome

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Apologies

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Declaration of conflicts of interest

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Applications for consent to distribute a new medicine under section 20 / 23 / 24 of the Medicines Act 1981 (referred by the Minister of Health under section 22(2))

4.1

COVID-19 AstraZenca, solution for injection (TT50-10877) AztraZeneca Limited

The product is a prescription medicine proposed for prevention of COVID-19 disease caused by SARS-CoV-2 in adults and adolescents from 18 years of age and older.

COVID-19 AstraZeneca is a recombinant replication-defective chimpanzee adenovirus vector-based vaccine for the prevention of coronavirus disease-19 (COVID-19) caused by the SARS-CoV-2 virus. The active substance is a new biological entity, ChAdOx1-S [recombinant]. COVID-19 AstraZeneca has been developed for prophylactic immunisation against coronavirus disease 2019 (COVID-19) in individuals aged 18 years and over.

The application was received by Medsafe on 29 January 2021. The application has undergone two rounds of request for information. The application is being considered for provisional consent under section 23 of the Medicines Act 1981 with proposed conditions.

The application is being referred to the Committee for independent advice as to whether the Minister of Health should grant provisional consent for the proposed indications. The Committee is also asked to consider all the particulars and information submitted by the applicant, and weigh the likely therapeutic value of the medicine against the risk, and the appropriateness of the conditions proposed for consent.

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General business

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Date of next meeting